Quality Control / Analytical Development Specialist

This laboratory-based role focuses on developing analytical methods, performing protein characterization, and supporting formulation development and stability programs for drug substance and drug product. You will work closely with a collaborative team to expand analytical and formulation capabilities while performing routine analytical testing in a quality-regulated environment. The role requires a hands-on scientist who can work independently, follow GxP and good documentation practices, and contribute to method development, transfer, and lifecycle support.

Responsibilities

• Develop and execute analytical methods to support process development, formulation development, and stability programs for drug substance and drug product.
• Perform analytical sample analysis using multiple techniques such as ELISA, HPLC, UV-Vis, plate-based assays, and related analytical instrumentation.
• Conduct analytical testing to support release and stability testing of drug substances, intermediates, and drug products.
• Draft test methods and procedures for routine sample analysis in a quality-regulated laboratory environment.
• Support identification and implementation of analytical science capabilities and technology tools to enable research, manufacturing, process development, quality control testing, and formulation development for new drug candidates.
• Maintain and organize the laboratory environment, including proper management of samples, reagents, consumables, and instruments.
• Assist with analytical method transfer, qualification, and validation activities for commercial quality control laboratories and contract testing laboratories.
• Contribute to the development of scientifically sound, data-driven specifications for analytical methods and product quality attributes.
• Prepare and help deliver technical reports, batch analyses, analytical methods, reference standard documentation, and other technical documents to support regulatory submissions.
• Apply appropriate levels of GxP, GLP, and GMP practices based on project scope and sample type, using a risk-based compliance mindset.
• Work effectively in a fast-paced, multi-project environment while collaborating with cross-functional teams.
• Ensure accurate, complete, and compliant documentation in alignment with good documentation practices.

• Hands-on experience performing analytical sample analysis using techniques such as ELISA, HPLC, UV-Vis, and plate-based assays.
• Proficiency with analytical instrumentation including HPLC systems (e.g., Waters or Thermo Fisher platforms) and plate readers.
• Working knowledge of cGMP, GxP, and GLP principles and their application in a quality-regulated laboratory environment.
• Experience with analytical method development and lifecycle support, including method development, transfer, qualification, and validation.
• Ability to apply appropriate levels of GxP/GLP/GMP based on project requirements and sample types, using a risk-based approach.
• Experience working in fast-paced, multi-project environments with multi-instrument analytical workflows.
• Strong organizational skills for managing samples, reagents, and laboratory equipment.
• Ability to prepare and review technical reports, analytical methods, batch analyses, and related documentation.
• Comfort working both independently and as part of a collaborative team.
• Strong attention to detail and commitment to good documentation practices.

• Passionate, proactive, and self-motivated attitude with a desire to thrive in a fast-paced, team-oriented environment.
• Experience handling multiple projects concurrently with differing levels of GLP oversight.
• Experience supporting release and stability testing for drug substances, intermediates, and drug products.
• Familiarity with Empower or similar chromatography data systems is beneficial.
• Experience supporting regulatory submissions through preparation of technical documentation is an advantage.
• Applicable professional laboratory experience is valued and can be considered in place of advanced educational degrees.
• Candidates with an associate degree and strong relevant experience are encouraged to apply.

The role is based in a fast-paced, team-oriented laboratory environment focused on analytical development, quality control, and formulation support. You will regularly work with advanced analytical instruments such as HPLC systems, plate readers, and related bioanalytical equipment while handling a variety of samples, reagents, and reference standards. The position involves managing multiple projects simultaneously in a regulated setting that follows cGMP, GxP, and GLP principles, with an emphasis on accurate documentation and data integrity. Collaboration with cross-functional teams in research, process development, manufacturing, and quality control is central to the work culture.

Job Type & Location

This is a Contract position based out of Durham, NC.

The pay range for this position is $40.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Durham,NC.

This position is anticipated to close on Apr 22, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.